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Strategy Development for Bacteriophage-Based Biopesticides - PS2151

Description
This project aims to review the current EU plant protection product (PPP) legislation in relation to microbial products, to identify how bacteriophage-based PPP could be regulated and areas in which current guidance is not appropriate. In addition, where appropriate, to provide recommendations on adaptive approaches and guidance on new methodology development. This interpretation may also provide useful guidance and information for the OECD Biopesticide Steering Group.

The desk-based study will review the current microbial PPP requirements, identifying key areas where interpretation and guidance might need to be considered or alternatively, if knowledge gaps exist. These conclusions will form the basis of a targeted literature search, which will be systematically reviewed for relevance and reliability and reported with standardised reporting by a specialist biopesticide professional.

The resulting review and analysis of knowledge gaps will allow the applicants to identify and propose appropriate waivers or study requirements, as well as appropriate new methodologies to produce the data required to register novel active substances based on bacteriophages under (EC) 1107/2009.
Additionally, within the desk study we will review the current state-of-the-art concerning applied bacteriophage research and IPR development in relation to PPP’s and associated areas (food production and safety).

The principal outcome of the project will be a proposed bacteriophage registration strategy document, which will have the potential to act as a basis for the OECD Biopesticide Steering Group, CRD, Defra and any other relevant authorities to discuss regulation of bacteriophage as biopesticides.
The project will be led and managed by Advanced Pest Solutions Ltd. (Dundee); an SME focussing on the development of bacteriophage for a range of plant-protection and food-processing applications, having direct experience with the relevant industries and a variety of public-sector grants to develop its technology. Critical to the success of the project will be the involvement (as a sub-contractor) of Dr Roma Gwynn (Rationale Biopesticide Specialists), whose recent work has made important contributions to the development and registration of new biopesticide active substances and products.
Objective
Specific evidence objectives are:
1. To establish a series of project planning and review meetings between all parties contributing to the study; all of the following objectives are dependent on having a robust project management strategy in place.
2. To assess the current regulation (EC) No. 1107/2009 and microbial guidance documents for bacteriophage biopesticides (APS, with strategic input from RBS).
3. Following review of (2), to develop a literature review protocol and define key review questions to allow a targeted literature search to be carried out (APS, with strategic input from RBS). [Dependent on successful completion of (2)]
4. To carry out a systematic review of the literature identified in (3). (RBS) [Dependent on successful completion of (3)]
5. To carry out a relevant IP audit regarding the commercial development of bacteriophage relating to food production, food safety and PPP (APS, with strategic input from Marks & Clerk LLP).
6. To review the commercial/regulatory state-of-the-art regarding developments of bacteriophage relating to food production, food safety and PPP (APS)
7. To collate the project’s data and information into a final report and bacteriophage biopesticide strategy document (APS, with strategic input from RBS). [Dependent on successful completion of objectives 1 – 6 above]
Project Documents
• EVID4 - Final project report : PS2151 Final report   (372k)
Time-Scale and Cost
From: 2013

To: 2013

Cost: £47,942
Contractor / Funded Organisations
Advanced Pest Solutions Ltd
Keywords
Biopesticide              
Microbial Growth              
Pesticide use              
Fields of Study
Pesticide Safety